MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-02-24 for RETROGUARD ARTERIAL SAFETY VALVE 4007100 manufactured by Quest Medical, Inc.
[101148554]
The complaint sample was evaluated and a longitudinal crack was seen on the housing of the valve. The nature of the crack suggests that the crack may have resulted from a blunt force impact on the device. The manufacturing process for this device involves a 100% visual and functional inspection. Each device is also functionally tested for leak, forward flow and retrograde flow. No lot number was provided by the customer to enable a dhr review. However, a 24 months complaint history review was completed for the part number and no similar complaint was identified. This complaint is an isolated incident and the root cause is unknown.
Patient Sequence No: 1, Text Type: N, H10
[101148555]
A report received from a customer states that a crack was seen on the retroguard valve during prime. The alleged issue did not result in any patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2018-00023 |
| MDR Report Key | 7294368 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-24 |
| Date of Report | 2018-02-23 |
| Date Mfgr Received | 2018-02-02 |
| Date Added to Maude | 2018-02-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TOSAN ONOSODE |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RETROGUARD ARTERIAL SAFETY VALVE |
| Generic Name | CPB CHECK VALVE |
| Product Code | MJJ |
| Date Received | 2018-02-24 |
| Model Number | 4007100 |
| Catalog Number | 4007100 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-24 |